Books Documentation Drug Development 
FDA Law Blog: Biosimilars
APRIL 8, 2025
OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Leading FDAs implementationof the Drug Competition Action Plan (DCAP).
FDA Law Blog: Biosimilars
DECEMBER 6, 2024
As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.
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Pharma Leaders
MAY 12, 2023
It makes sense of everything successful drug and device manufacturers must know and do, delivering the news, analysis and interpretation of industry changes you need to stay in compliance and thrive.
Viseven
AUGUST 7, 2024
As most documents come in a PDF format, Adobe Acrobat is helpful for this task. As stated by Cynthia Kryder in the book ‘The Accidental Medical Writer,’ you have to spend money to make money. Essential resources include a nursing procedure book, physician desk reference, and medical dictionary.
pharmaphorum
DECEMBER 6, 2022
Iddo Peleg (CEO, and one of the four co-founders of YonaLink) and Gav Martell (co-founder and vice president of business development) discussed how a recent $6 million funding round led by Debiopharm Innovation Fund will support their mission to transform clinical trials and bring lifesaving therapies to market faster.
pharmaphorum
JANUARY 18, 2022
Smart device developers. Training device developers. Drug developers. BOOK BY 17 th DECEMBER AND SAVE $400. BOOK BY 31 st JANUARY AND SAVE $200. BOOK BY 28 TH FEBRUARY AND SAVE $100. Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion.
Putting Patients First Blog
FEBRUARY 6, 2024
The price of progress: funding and financing Alzheimer’s disease drug development. autm.net/AUTMMain/media/Partner-Events/Documents/Economic-_Contribution_University- Nonprofit_Inventions_US_1996-2015_BIO_AUTM.pdf 16 Lanahan, L., bi.nlm.nih.gov/books/NBK196184/ 24 National Health Council. Nature Communications, 11(6265).
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